MAUDE Adverse Event Report: RAYNHAM CEREBROFLO EVD CATHETER KIT; NEURO

Model Number	37.550.501
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical study: patient had on (b)(6) 2021 a cerebroflo evd catheter placed to treat secondary intraventricular hemorrhage (ivh) due to ruptured aneurysm.On (b)(6) 2021 it was reported the cerebroflo evd catheter was leaking at exist site.A ct scan on (b)(6) reveals some air in the ventricles and it was considered replacing her evd, but was deferred as it was felt the air was entrained from around the evd rather than due to malfunction of evd.An additional suture was placed at the exit site and the outcome was recovered/resolved and the catheter was removed on (b)(6) 2022.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The cerebro evd catheter (id 37550101) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CEREBROFLO EVD CATHETER KIT
• Common Device Name: NEURO
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13790695
• Report Number: 3014334038-2022-00054
• Device Sequence Number: 4022775
• Product Code: JXG
• UDI-Device Identifier: 10866614000105
• UDI-Public: 10866614000105
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2023
• Device Model Number: 37.550.501
• Device Catalogue Number: 37550101
• Device Lot Number: 37862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/21/2022
• Date Device Manufactured: 04/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 131 KG